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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06082037
Registration number
NCT06082037
Ethics application status
Date submitted
7/10/2023
Date registered
13/10/2023
Date last updated
4/07/2025
Titles & IDs
Public title
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study, Followed by Open-label Extensions, to Evaluate the Efficacy of Oral Belumosudil in Adult Participants With Chronic Lung Allograft Dysfunction (CLAD) Following Bilateral Lung Transplantation
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Secondary ID [1]
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U1111-1280-6777
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Secondary ID [2]
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EFC17801
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Universal Trial Number (UTN)
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Trial acronym
ROCKaspire
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Transplant Rejection
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Belumosudil
Treatment: Drugs - Azithromycin
Treatment: Drugs - Placebo
Experimental: Belumosudil + Azithromycin - Participants will receive 200 mg belumosudil orally once daily
Placebo comparator: Placebo + Azithromycin - Participants will receive placebo orally once daily
Treatment: Drugs: Belumosudil
Tablet, Oral
Treatment: Drugs: Azithromycin
Depends on pharmaceutical presentation, Oral
Treatment: Drugs: Placebo
Tablet, Oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 26
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Secondary outcome [1]
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Response rate at Week 26
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Assessment method [1]
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Defined as the proportion of participants with =10% decline in FEV1 at Week 26 compared with baseline
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Timepoint [1]
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Baseline to Week 26
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Secondary outcome [2]
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Absolute change from baseline to Week 26 in FEV1
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Assessment method [2]
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Timepoint [2]
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Baseline to Week 26
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Secondary outcome [3]
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Absolute change from baseline to Week 26 in percent predicted FEV1
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Assessment method [3]
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Timepoint [3]
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Baseline to Week 26
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Secondary outcome [4]
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Percent change from baseline to Week 26 in forced vital capacity (FVC)
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Assessment method [4]
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Timepoint [4]
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Baseline to Week 26
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Secondary outcome [5]
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Absolute change from baseline to Week 26 in FVC
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Assessment method [5]
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Timepoint [5]
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Baseline to Week 26
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Secondary outcome [6]
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Absolute change from baseline to Week 26 in percent predicted FVC
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Assessment method [6]
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Timepoint [6]
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Baseline to Week 26
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Secondary outcome [7]
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Time to CLAD progression during the double-blind treatment period
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Assessment method [7]
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Defined as the first of the following events: \>10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death
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Timepoint [7]
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Baseline to Week 26
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Secondary outcome [8]
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Time to re-transplantation or death
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Assessment method [8]
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Timepoint [8]
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Up to 7 days after the administration of last dose of study drug
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Secondary outcome [9]
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Percent change from baseline to Week 26 in 6-minute walk distance
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Assessment method [9]
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Timepoint [9]
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Baseline to Week 26
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Secondary outcome [10]
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Absolute change from baseline to Week 26 in 6-minute walk distance
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Assessment method [10]
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Timepoint [10]
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Baseline to Week 26
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Secondary outcome [11]
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Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)
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Assessment method [11]
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Total score and scores by domain
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Timepoint [11]
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Secondary outcome [12]
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Change from baseline to Week 26 in EQ-5D-5L
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Assessment method [12]
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Visual analogue scale and individual dimensions
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Timepoint [12]
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Secondary outcome [13]
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Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1
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Assessment method [13]
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Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) profile V2.1 (domain scores)
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Timepoint [13]
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Baseline to Week 26
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Secondary outcome [14]
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Number of participants with adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [14]
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Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), as well as laboratory abnormalities during the double-blind treatment period and the open-label extensions
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Timepoint [14]
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Up to 7 days after the administration of last dose of study drug
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Eligibility
Key inclusion criteria
* Participant =1 year post bilateral lung transplantation at the time of screening
* Participants presenting with CLAD Stage 1 or 2: FEV1 from >50% to 80% of post-transplant baseline at screening and at randomization
* Participants who have received at least 8 weeks of azithromycin (=250 mg/day, at least 3 times a week) prior to randomization
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* FEV1 =50% of the post-transplant baseline value (CLAD 3 and 4)
* Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/06/2028
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Investigational Site Number : 0360003 - Sydney
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Recruitment hospital [2]
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Investigational Site Number : 0360001 - Brisbane
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Recruitment hospital [3]
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Investigational Site Number : 0360002 - Murdoch
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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4032 - Brisbane
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Recruitment postcode(s) [3]
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6150 - Murdoch
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Recruitment outside Australia
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Alabama
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Fuzhou
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Hangzhou
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.
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Trial website
https://clinicaltrials.gov/study/NCT06082037
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Email
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Contact person for public queries
Name
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Trial Transparency email recommended (Toll free number for US & Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06082037
Download to PDF